Ethiopian Food and Drug Authority
Guideline for Registration and Import Permit of
Medical Device Accessories and Spare Parts
First Edition
July 2021
Addis Ababa, Ethiopia
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Table of Contents
Table of Contents ........................................................................................................................................... i
ACRONYMS ................................................................................................................................................... ii
ACKNOWLEDGEMENT .................................................................................................................................. iii
OVERALL SUMMARY OF THIS GUIDELINE .................................................................................................... iv
1 INTRODUCTION ..................................................................................................................................... 1
2 SCOPE .................................................................................................................................................... 2
3 PURPOSE ............................................................................................................................................... 2
4 DEFINITIONS .......................................................................................................................................... 2
5 GENERAL PRINCIPLES ............................................................................................................................ 2
6 APPROACHES FOR IDENTIFICATION OF MEDICAL DEVICE ACCESSORIES AND SPARE PARTS ............... 3
7 APPLICATION REQUIREMENTS, EVALUATION AND APPROVAL PROCESSES ......................................... 5
7.1 Application for Marketing Authorization Certificate .................................................................... 5
7.1.1 Administrative requirements ................................................................................................ 5
7.1.2 Technical requirements of Accessories and Spare parts ...................................................... 6
7.2 Application for Import Permit of unregistered Accessories and Spare Parts ............................... 8
8 SOME EXAMPLES OF ITEMS WHICH ARE NEITHER ACCESSORY NOR SPARE PART AND THEREFORE
DO NOT NEED EFDA’S APPROVAL ................................................................................................................. 9
9 REFERENCE .......................................................................................................................................... 10
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ACRONYMS
EFDA Ethiopian Food and Drugs Administration
ISO International Standards Organization
USB Universal Serial Bus
eRIS Electronic Regulatory Information System
NGO Non-governmental Organization
MA Market Authorization
GMP Good Manufacturing Practice
CE European Conformity
USFDA U.S. Food and Drug Administration
CAPA Corrective Action and Preventive Action
EU European Union
NB Notified Body
SUD Single Use Device
TGA Therapeutic Goods Administration – Australia
IRB Institutional Review Board
IMDRF International Medical Device Regulators Forum
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ACKNOWLEDGEMENT
Ethiopian Food and Drug Authority is very grateful to those who have participated directly or
indirectly in preparing this Guideline.
The Authority would like to express its special thanks and appreciation to the following experts
who have dedicated their time, energy and resource to contribute to develop this Guideline from
its drafting until its approval.
Keneni Benti (MSc in Biomedical Engineering), Medical Device Registration Dossier
Assessor at EFDA
Selamawit Asfaw (Chief Biomedical Engineer), Medical Device Registration Dossier
Assessor at EFDA
Solomon Shiferaw (Senior Pharmacist), Technical Advisor, EFDA
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OVERALL SUMMARY OF THIS GUIDELINE
Items type: Accessories and Spare parts
Regulation scope: Marketing Authorization certificate issuance and Import permit
Establishments to be given permission: Importers of parent devices, importers of these items,
maintenance centers, manufacturers, healthcare facilities, NGOs, etc.
Importation of unregistered Accessories and Components by:
Medical device importer of the same parent device from the manufacturer other than parent
device manufacturer.
Accessories and components importer from the manufacturer other than parent device
manufacturer.
Healthcare facilities importation permit from the manufacturer other than parent device
manufacturer.
Medical Equipment Maintenance center importation permits from the manufacturer other
than parent device manufacturer.
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1 INTRODUCTION
The Food and Medicine Administration Proclamation (Proclamation No. 1112/2019) states that
medical devices shall be registered and granted marketing authorization before being made
available for public use. The registration process requires assessment of quality, safety and
performance of the medical device. Furthermore, the rigor of regulatory assessment of medical
device shall be commensurate with the device type, nature, and potential risk to human health.
Medical device refers to an instrument, apparatus, implement, medical equipment, machine,
contrivance, implant, in vitro reagent, or other similar or related article, including any component,
part or accessory, that is:-
a) recognized in a pharmacopoeia or any supplement to it;
b) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation,
treatment, or prevention of disease, in human being or;
c) intended to affect the structure or any function of the body of a human being and which
does not achieve any of its principal intended purposes through chemical action within the
body of a human being and is not dependent upon being metabolized for the achievement
of any of its principal intended purposes.
All articles, including accessories, that meet the definition of “medical device” above are regulated
under article 2(22) of the Authority’s Proclamation No: 1112/2019.
Through this guideline, EFDA would like to give clear guidance for applicants to submit relevant
supporting documents for registration and importation permit of medical device accessories and
spare parts. In addition, this guideline explains the type of devices that are considered as an
“accessory” and “spare part” and describes the processes to allow requests and pathways for
issuance of marketing authorization certificate and one time import permit of these accessories and
spare parts as per the requirements set in this guideline.
This information is expected to provide a greater level of transparency with regards to the
regulatory requirements of accessories and spare parts and will aid the Authority’s staff and
industry in assuring that the medical devices are subject to the appropriate level of regulatory
oversight by EFDA.
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2 SCOPE
This guideline is applicable for marketing authorization and one time importation permit of
medical device accessories and spare parts which are to be imported or locally manufactured.
This guideline is not applicable for accessories that are registered as a part of the parent medical
devices.
3 PURPOSE
The purpose of this guideline is to provide guidance for applicant on marketing authorization
registration and import permit medical devices accessories and spare parts.
4 DEFINITIONS
Accessory: - A finished device that is intended to support, supplement, and/or augment the
performance of one or more parent devices. Accessories are designed specifically for a device, and
may include consumables, parts, add-ons, and other components for use in conjunction with, or
for upgrade, replacement and repair of parts of a medical device.
Component: - Any raw material, substance, piece, part, software, firmware, labeling, or assembly
which is intended to be included as part of the finished, packaged, and labeled device.
Spare part:- Is a part for replacement of existing components of a device, the conformity of which
has already been established.
Finished Device: - Any device or accessory to any device that is suitable for use or capable of
functioning, whether or not it is packaged, labeled, or sterilized.
Parent Device: - A finished device whose performance is supported, supplemented, and/or
augmented by one or more accessories.
5 GENERAL PRINCIPLES
Accessories or Components (parts) which are together with the parent devices during the device’s
premarket registration application can be applied as a “system” together with the parent devices.
EFDA has a guideline on ‘how to group medical device and its accessories and components for
registration application purpose as a “system” so as to make one application’.
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EFDA intends to determine the risk of accessories and spare parts and the regulatory controls
necessary to provide a reasonable assurance of their safety and effectiveness according to their
intended use.
Because accessories are intended to be used with and to support, supplement, and/or augment one
or more parent devices and spare parts intended to replace component(s) of a parent device, EFDA
intends to determine the risks of accessories and spare parts when used, as intended, with the parent
device type.
Determining the risks of accessories and spare parts according to their use with parent devices
does not mean that all risks of a parent device are imputed to the accessory or spare part; the risk
profile of an accessory or spare part can differ significantly from that of the parent device,
warranting differences in regulatory classification. In determining the classification of an
accessory or spare part, EFDA intends to evaluate the risks imposed by the accessory’s or spare
part’s impact on the parent device and any unique risks of the accessory independent of its parent
device.
As with the classification of any other device, the types of regulatory controls necessary to control
these risks of the use of the accessory and spare part with the parent device will determine the
regulatory control for accessories and spare parts.
Accessories and spare parts need to be given independent risk- and regulatory control-based
classification to that of the parent devices. These accessories and spare parts class can be the
same or lower than that of the device(s) with which they are intended to be used.
6 APPROACHES FOR IDENTIFICATION OF MEDICAL DEVICE
ACCESSORIES AND SPARE PARTS
The accessory and spare parts classification process begins with the analysis of whether the article
under consideration is an accessory or spare part or not. Following identification of the item as
accessory or spare part or neither of them, this particular item’s impact on the parent device’s
safety and performance should be assessed. This is because the registration (marketing
authorization) and importation permit requirements depend on the significance of the effects that
can be caused by the requested accessory or spare part on the parent device’s safety and
performance. Hence, the manufacturers of the accessories and spare parts are responsible to
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determine the risk level of their accessories and spare parts depending on the items impact on the
parent medical device’s intended use.
The Item type
Application
type?
Spare part Accessory Does not fulfil the definition of
accessory or spare part
Registration certificate
request
Importation
permit request Follow section 7.1
of this guideline
Follow section 7.2
of this guideline
Figure 1: Flowchart for accessory and spare part identification and dossier requirements
Does not need EFDA’s Approval
(Refer to section 8).
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7 APPLICATION REQUIREMENTS, EVALUATION AND APPROVAL
PROCESSES
There are a number of scenarios to submit and get approval for the request of importation permit
or issuance of market authorization certificate for medical device accessories and spare parts.
These approaches are divided based on the following concepts:-
Application submission for issuance of marketing authorization certificate of Medical
device accessories or spare parts by an establishment (importer or registrant) who is
engaged in the business of medical device and/or medical device accessories and spare
parts importation and/or registration.
Application submission of request for importation permit of unregistered Medical device
accessories and spare parts by healthcare facilities, NGOs, Government agencies, licensed
medical device installation and maintenance centers.
7.1 Application for Marketing Authorization Certificate
Establishments licensed by EFDA and engaged in Registration and/or importation of medical
devices and/or their accessories and spare parts are expected to submit all required applicable
documents described under section 7 of this guideline for registering their products. The applicants
should get the login details of the Authority’s online registration platform from an authorized
person to request for issuance of marketing authorization certificate. No person or company can
apply for the marketing authorization certificate before being licensed by the Authority to register
and/or import such products.
7.1.1 Administrative requirements
The applicant shall fill the application form online in the eRIS information system
Cover letter: The license holder/marketing authorization holder should provide an original
cover letter (with the company’s original stamp and an authorized person’s signature from
the company) describing that the applicant (local agent) mentioned on the letter is the one
authorized to submit the application for registration of the medical device accessories or
spare parts described on the letter. The content and format should be as per the template
in Annex III of General Guidelines for Medical device Marketing Authorization by only
replacing device’s name by accessory’s or spare part’s name.
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An agency agreement made between the manufacturer of the medical device accessories
or spare parts and the agent responsible for the registration and/or import, distribution, and
sale of the product in Ethiopia.
Copy of market authorization certificate of the parent medical device or if the parent
medical device is not registered, evidence that the parent device are available for use in
health facility(ies) of Ethiopia.
Free sale certificate (as applicable). The free sale certificate issued by the competent
national regulatory authority, which indicates the name(s) of the medical device
accessories (with model if applicable) and explains whether the accessories are freely sold
in the country of origin should be provided; if not, the reasons thereof should be clearly
stated with appropriate justification.
Declaration of conformity
Quality management system confirmatory statement such as CE or ISO certificate
(applicable if the manufacture of accessary is not registered previously)
Evidence of payment for registration as indicated in the fee service regulation of the
authority.
Applicants who need to import medical device accessories and spare parts shall be
consistent with the recent Medicine and Medical device import, export and wholesale
directive of the Authority
7.1.2 Technical requirements of Accessories and Spare parts
In order to streamline the submission and evaluation of the safety and effectiveness of accessory
or spare part, applicant should provide the following technical information:
a) Clear and detail description of the accessory or spare part and its intended use when used
with the parent device(s).
b) Device Information and Summary:
A description of the relevant parent device(s);
Identification of parent product(s) to which the accessory or spare part is compatible,
including model number of parent device, connector type, etc.;
A description of the ability for the spare part or accessory to be compatible with a
specific parent device, multiple parent devices, or a class of devices;
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A description of the technical characteristics of the accessory or spare part, which
ensure compatibility with a specific parent device, multiple parent devices, or a class
of devices;
A description of how the accessory supports, supplements and/or augments the
performance of the parent device.
c) Classification summary and recommendation:
The accessory should be classified as per the guidelines for medical device
classification of the Authority.
The classification summary should include a rationale for why the accessory or spare
part does not fit within any identified classification for the parent device(s);
d) An identification of the risks to health presented by the accessory or spare part and
proposed mitigation measures;
e) Summary of the safety and performance data supporting the registration of the accessory
or spare part:
Reference to all reasonably known relevant data and information, including new
information, about the accessory or spare part in combination with the parent
device(s);
f) Labeling for the accessory and spare part with adequate instructions for use with the parent
device(s): The labeling information should include
Name of the accessory or spare part, model/serial number, name and address of
manufacturer and manufacturing site,
Include labeling instructions to address compatibility of the new accessory device
and the parent device(s), including any relevant performance data to support
compatibility;
Include relevant technical characteristics of the accessory,
If the accessory is sterile, such information should be reflected in the labeling
information.
If the accessory is single use only, such information should be reflected in the labeling
information:
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7.2 Application for Import Permit of unregistered Accessories and Spare
Parts
Establishments such as healthcare facilities, NGOs, government agencies, licensed medical device
installation and maintenance centers can request the Authority for importation permit of medical
device accessories or spare parts.
Import permit application requirements:-
Filling all necessary and applicable product’s information (of the accessory and spare part)
required on eRIS.
Dated and signed cover letter by the requesting establishment.
Appropriate Proforma Invoice
Marketing Authorization certificate or Import permit approval certificate issued for the
parent device by EFDA. (Other means of verifying the parent device’s approval by EFDA
is also acceptable).
Marketing Authorization certificate or free sale certificate or relevant ISO standard
conformance certificate for the requested accessories and spare parts. (Optional).
Declaration of conformity by the manufacturer of the accessory or spare part under
evaluation.
Note
No medical device accessories or spare parts shall enter in to the country without prior
permission of the Authority.
If the medical device accessories and spare parts are to be supplied by donation, applicant
shall follow the recent relevant document(s) of the Authority to understand the applicable
requirements.
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8 SOME EXAMPLES OF ITEMS WHICH ARE NEITHER ACCESSORY
NOR SPARE PART AND THEREFORE DO NOT NEED EFDA’S
APPROVAL
An article meets one or more of the following criteria’s may not be considered as a medical device
accessory or spare part. Applicants of such products should not make any request to the authority
for their registration or importation.
1. An Item that does not fulfil the definition of medical device accessory or spare part.
2. If a replacement part or component which can be purchased off-the shelf. Example:
Batteries, USB cables and printers, which can be purchased from off-the shelf and not
fall in medical device definition.
A mobile phone that is used as a general platform for applications that include mobile
medical applications that are medical devices, or an off-the-shelf computer monitor
used to display medical data would not be considered accessories unless they are
intended for use with such devices by the labeling and promotional materials.
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9 REFERENCE
1. Definition of Medical Device, Medical Device Guidance Document, Ref. No.
MDA/GD/0006, 1stEdition, Medical Device Authority, Ministry of Health, Malaysia,
March 2014.
2. Medical Device Accessories-Describing Accessories and Classification Pathways,
Guidance for Industry, USFDA, December 2017.
3. Guideline for Registration of Medical devices, 3rd Edition, Food and Drug Authority of
Ethiopia, September 2014.
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